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Product image for 2 Day Virtual Seminar on FDA Inspection Essentials in 2022

2 Day Virtual Seminar on FDA Inspection Essentials in 2022

MP3 Download This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol

Course•By Danielle DeLucy

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Product image for 2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

MP3 Download This 2 day seminar will go into the specifics of the REACH and RoHS regulations

Course•By Kelly Eisenhardt

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Product image for 21 CFR Part 11 Compliance for SaaS/Cloud Application

21 CFR Part 11 Compliance for SaaS/Cloud Application

MP3 Download This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors

Course•By David Nettleton

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Product image for EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

MP3 Download This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share le

Course•By Kelly Thomas

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Product image for Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit

Course•By Michael Ramcharan

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Product image for All About Data Integrity by Design

All About Data Integrity by Design

MP3 Download The course provides insight into the ways in which Pharma 4.0™ will serve as an enabler for next generation medicinal products and new business cases for established products

Course•By Carolyn Troiano

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Product image for Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course

Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course

Dec 11-12 The objective of this live, interactive WCS training seminar is to explore the role of aseptic filling to assure that manufactured product

Course•By Barry A. Friedman

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Product image for Biostatistics for the Non-Statistician

Biostatistics for the Non-Statistician

Sep 16-18 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

Course•By Elaine Eisenbeisz

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Product image for Biostatistics for the Non-Statistician

Biostatistics for the Non-Statistician

MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

Course•By Elaine Eisenbeisz

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Product image for Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product

Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product

MP3 Download In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations

Course•By Karl M. Nobert

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Product image for Computer System Validation for Cloud and COTS Applications–Live, Online Training

Computer System Validation for Cloud and COTS Applications–Live, Online Training

MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry

Course•By Carolyn Troiano

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Product image for EU Clinical Trial Regulation 536/2014: Compliance, Implementation & Best Practices

EU Clinical Trial Regulation 536/2014: Compliance, Implementation & Best Practices

MP3 Download This course covers the requirements for conducting Clinical Studies across the EU

Course•By John E Lincoln

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Product image for FDA Recalls - Before You Start, and After You Finish

FDA Recalls - Before You Start, and After You Finish

Jan 21-22 This seminar will help you to Understand FDA's recall authority and policy

Course•By Kelly Thomas

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Product image for Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

MP3 Download This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend

Course•By Kelly Thomas

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Product image for Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

Jan 22-23 This seminar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles

Course•By John E Lincoln

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Product image for Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents

Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents

MP3 Download this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.

Course•By Kelly Thomas

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Product image for Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

MP3 Download The lifecycle concept, new to these Guidance, link product and process development, qualification

Course•By Barry A. Friedman

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Product image for Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

MP3 Download This virtual seminar will address those project management critical tasks within each project phase that must be performed

Course•By Charles H. Paul

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Product image for Quality Control Laboratory Compliance - cGMPs and GLPs

Quality Control Laboratory Compliance - cGMPs and GLPs

MP3 Download This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions

Course•By Kelly Thomas

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Product image for Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.

Course•By David Nettleton

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Product image for Regulatory Compliance for Dietary Supplements in the US, EU and Canada

Regulatory Compliance for Dietary Supplements in the US, EU and Canada

Jan 15-16 This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada

Course•By Travis Austin MacKay

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Product image for Risk-based Computer System Validation; Reduce Costs and Avoid 483s

Risk-based Computer System Validation; Reduce Costs and Avoid 483s

This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors

Course•By David Nettleton

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Product image for Statistical Process Control (SPC) Training

Statistical Process Control (SPC) Training

MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality

Course•By Elaine Eisenbeisz

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Product image for Technical Writing for professionals in the life sciences

Technical Writing for professionals in the life sciences

MP3 Download This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents

Course•By Charles H. Paul

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